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Anna Santilli is a Site Manager and Project Engineer at cGMP Consulting Inc., with 4 years of experience focusing on Quality and Validation. Anna enjoys the challenge of investigational Tech Writing with discussions among Subject-Matter Experts to assess impact, identify causal factors, and assign corrective actions. She also has experience in implementation and validation of Electronic Batch Record systems. Her current work emphasizes quality as a Technical Reviewer for equipment and systems validation from Design Qualifications to Decommissioning.
Anna graduated from Marquette University with a degree in Biomedical Engineering with a concentration in Bio-Computing. Outside the office, she enjoys reading fantasy, science fiction, and mysteries—fueled by her love of problem-solving.
Jim Clarke is a Site Manager and a Senior Project Engineer at cGMP Consulting Inc., bringing over 4.5 years of specialized experience in Installation, Operational, and Performance Qualification of various equipment used in the production of vials and pre-filled syringes. He has validated several pieces of equipment, specifically in component preparation, including Parts Washers, Autoclaves, Terminal Sterilizers and Filter Integrity Testers. He has extensive experience in Cleaning Validation and Sterilization. Jim also has experience in temperature mapping warehouses and temperature-controlled equipment and rooms.
Within cGMP Consulting, Jim oversees a growing team of 5 engineers, meeting the needs and driving projects at the client.
Jim graduated from the University of Louisville with a degree in Chemical Engineering. He also has a Lean Six Sigma Green Belt. Outside of the office, he enjoys fishing, golfing, home remodeling, and traveling.
Spencer Dotseth is a Site Manager and Project Engineer at cGMP Consulting Inc., bringing over 4 years of experience in the pharmaceutical industry. He has experience with design, installation, and operational qualifications for a priority complex formulation line, as well as managing warehouse renovations and training client personnel on manufacturing execution systems.
He has supported numerous product transfers and new product introductions through his experience as a business systems analyst, including the authoring of production recipes through SAP and POMSnet.
Spencer graduated with a Bachelor of Science in Mechanical Engineering from the University of Iowa, complemented by a minor in Mathematics. Outside of the office, he enjoys travelling and enjoying time with family and friends.
Anthony Kluch is Employee Engagement Coordinator and Sr. Project Engineer at cGMP Consulting Inc, leveraging over 4 years of extensive experience in the pharmaceutical industry. His expertise spans a wide array of projects, including the qualification of aseptic filling lines, component preparation equipment, and cleaning validation.
Within cGMP Consulting, Anthony oversees the planning and running of company events. Additionally, Anthony assists in hiring staff and placement of current employees.
Anthony holds a Bachelor’s Degree in Chemical Engineering from the University of Iowa. Outside the office, he enjoys climbing and cooking.
Ashlee Hart is a Site Manager and Project Engineer at cGMP Consulting Inc., specializing in Installation, Operational, and Performance Qualification for various equipment used in the production of excipients and APIs. She has extensive experience in temperature mapping temperature-controlled equipment and rooms, including refrigerators, freezers, stability chambers, and warehouses. She has validated several different pieces of equipment including stills, stability chambers and recirculators, and a laboratory muffle furnace. Finally, she has experience in performing Periodic Quality Evaluations for equipment, utilities, and water systems.
Ashlee graduated from the University of Wisconsin – Madison with a degree in Biomedical Engineering and a certificate in Biology in Engineering.
Courtney Mansour is a Site Manager and Project Engineer at CGMP Consulting Inc. with 3 years of experience. Her career began in commercial quality in the pharmaceutical field focusing on investigating potential falsified medicines.
She also has experience in supply chain traceability with serialization, data migration, and routinely investigates batch file issues. Her expertise extends to leading the qualification of numerous shippers for cosmetic and medical cold chain products.
Courtney graduated with a Bachelor of Science in Mechanical Engineer and a certificate in leadership. Outside of the office, she enjoys traveling, going to concerts, and spending time with her dog.
Nolan Horan is a Key Account Manager and Project Engineer at cGMP Consulting Inc, leveraging over 4 years of extensive experience in the pharmaceutical industry. His experience spans a wide array of projects, including the qualification of aseptic filling lines and environmental monitoring systems, product quality investigations, packaging operations, capital project management, and integration of robotics and automated systems.
Within cGMP Consulting, Nolan serves as Key Account Manager with a large pharmaceutical client in the Chicagoland area. He excels at fostering strong relationships between clients and cGMP Consulting. He strives to ensure seamless communication, alignment on project goals, and ongoing support to drive operational success and client satisfaction.
Nolan holds a Bachelor’s Degree in Chemical Engineering from the University of Iowa, complemented by a minor in Business Administration. Beyond his professional endeavors, he finds joy cooking and the continuous pursuit for lower scores on the golf course.
Celine Lam is a Business Administrator and Marketing professional at cGMP Consulting Inc. who adeptly manages and oversees various aspects of company operations, marketing initiatives, and administrative tasks. Celine has experience in crafting project proposals, overseeing project accounting activities, and developing standardized procedures for regulatory compliance. Her expertise extends to marketing, where she conceptualizes graphics, optimizes website structures for enhanced user experience, develops engaging content, and manages social media platforms.
Celine Lam graduated with a Master of Science in Business Administration, focusing on International Management from the University of Illinois at Urbana – Champaign and a Bachelor of Science in Marketing Management from the University of Iowa. Outside of the office, Celine enjoys traveling, skiing, aerial yoga and spending time with family and friends.
Andrea Bates is the Manager of Business Development at cGMP Consulting Inc., where she plays a pivotal role in introducing the company’s services and benefits to both new and existing clients. With nearly 20 years of experience in sales and account management, Andrea is well-versed in actively listening to clients’ needs and identifying best in class tailored solutions to address their pain points effectively.
Focused on being a valuable resource to our clients, Andrea prioritizes continuous education ensuring she is up to date on all the latest FDA regulatory news and developments. She is dedicated to delivering optimal client experience and helping clients achieve their business goals. Andrea takes great pride in operating with the highest of integrity.
Andrea graduated with a Bachelor of Arts in Speech Communication and a minor in Sociology from Augustana College. Outside of the office, she enjoys traveling, playing volleyball, running and above all spending quality time with her family and friends.
Upasana Pathak is a Validation Engineer with experience in pharmaceutical industry qualifications. She has experience validating new filling line equipment, SIP/CIP SKID cleaning equipment, and developing validation processes for Enterprise Resource Planning (ERP) systems, ensuring compliance with regulatory standards and industry best practices. She also serves as Project Manager for complaint handling software launches.
Internally, she is the Training Coordinator at cGMP Consulting Inc., coordinating and managing the training and development program, ensuring that staff members are equipped with the necessary skills and knowledge to excel in their roles.
Upasana graduated with a Bachelor of Science in Biomedical Engineering from Northwestern University. Outside of the office, Upasana enjoys reading and working with a non-profit focusing on Academic Global Surgery.
Kajal Modi is a Project Engineer at cGMP Consulting Inc., specializing in driving Change Plan development for various global packaging projects. She also has experience in conducting temperature profiling for warehouses, chambers, trailers, and other facilities, ensuring optimal storage conditions for products.
Additionally, she serves as the Event Coordinator at cGMP Consulting, playing a key role in organizing and facilitating company-wide events to nurture a strong team culture. She also supports initiatives for employee recognition and development.
Kajal graduated with a Bachelor of Science in Chemical and Biomolecular Engineering from the University of Illinois at Urbana-Champaign. Outside of the office, Kajal enjoys the craft of sewing and rollerblading.
Rachel Sitko is Personnel Director at cGMP Consulting Inc. with over 4 years of experience supporting Validation projects including the qualification of formulation bays, filling lines, and EMS systems, while overseeing the hiring of new staff. She has valuable experience in supporting FDA audits and Pre-Approval Inspections (PAIs) for new vial filling lines.
In her internal cGMP Consulting role, she is responsible for the vital tasks of screening, interviewing, hiring, and placing new and existing staff members. Additionally, Rachel takes the lead in organizing career fairs and other events to support employee engagement.
Rachel graduated with a Bachelor of Arts in Chemistry and a minor in Mathematics from Monmouth College. Outside of the office, she enjoys coaching swimming and water polo at her former high school.
Esmeralda Orozco is a Site Manager and Project Engineer at cGMP Consulting Inc., bringing a wealth of experience and expertise to her role. Her primary area of focus centers on fill/finish equipment projects where she executes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) procedures for critical components including Vial Washers, Depyrogenation Tunnels, Filling Machines, Automatic Loading/Unloading Systems, Lyophilizers, and Capping Machine/Crimp Inspection. Previously, she led the qualification of a Water-for-Injection (WFI) storage and distribution system and provided support for qualifying other critical utilities. She effectively manages teams of up to 6 employees, ensuring project health and client satisfaction through personalized mentoring sessions.
Esmerelda graduated with Bachelor’s degree in Chemical Engineering, with a focus area in Business and Pharmaceuticals, from the University of Iowa. Outside of the office, she enjoys lifting weights and hiking in her free time.
Alex Garcia is a Site Manager and Project Engineer at cGMP Consulting Inc. with 5 years of experience. His proficiency lies in effectively identifying and addressing root causes of non-conformance events across manufacturing departments, driving continuous improvement through the proposal and implementation of corrective and preventive actions (CAPAs).
Alex’s expertise extends to leading the qualification of various pieces of equipment, including tray packers and vial labelers. He has contributed to the development of Installation Qualification (IOQ) packages for various equipment used by contract manufacturers and cannabis companies. Alex has also played a key role in developing quality manuals for start-up companies, demonstrating his solid understanding of regulatory requirements.
Within cGMP Consulting, Alex has demonstrated his leadership capabilities by authoring numerous Standard Operating Procedures (SOPs) utilized by the company and effectively managing a team of project engineers.
Alex graduated with a Bachelor’s degree in Biomedical Engineering from the Illinois Institute of Technology. Outside of work, Alex enjoys weightlifting, reading, video gaming, and tackling DIY projects.
John Nielsen is the Key Account Manager at cGMP Consulting Inc., supporting a diverse range of capital projects within the pharmaceutical field since joining the company in 2018. John began his career with a focus on the manufacture of high-potency products, supporting the build-out of new and re-furbished aseptic manufacturing facilities. These projects encompassed a wide variety of facility, utility, and equipment types and the management of their respective lifecycles within a quality environment.
John has spent the last few years supporting a client’s global Track-and-Trace initiative, assisting in the deployment, management, and upkeep of the clients Track-and-Trace hardware and software across their packaging network.
In his role as Key Account Manager, John prioritizes fostering an open and constructive environment for his staff, supporting their career and skills development. He actively manages day-to-day client relations and provides essential administrative support to drive the business forward. Through routine check-ins and collaborative problem-solving sessions, John ensures that his team is equipped to navigate challenges effectively and deliver exceptional results.
John graduated with a Bachelors in Biochemistry from the University of Wisconsin – Madison. He lives in Chicago with his wife Elena and two cats. Outside of the office, John likes to pursue outdoor hobbies such as kayaking, canoeing, scuba diving, and biking. John is an avid Chicago Cubs fan – loving both the sounds of the park and the routine of the season.
Marlis Owen is Quality Engineering Director at cGMP Consulting Inc., specializing in Project Management, Quality System Development, and Validation. She has a passion for helping clients achieve operational excellence and compliance with current Good Manufacturing Practices. She directs teams at multiple clients in industries including injectable pharmaceuticals, excipients, dietary supplements, medical devices, animal food, cannabis, and hand sanitizer. She serves as Project Manager for biologic combination product launches. Internally, she also manages the development and auditing programs.
Marlis graduated with a Bachelor of Science in Chemical Engineering and minor in Business Administration from the University of Iowa.
Luis Nieves is a seasoned Senior Auditor with 38 years of experience in the pharmaceutical and biotech industry. Luis has honed his expertise in navigating the intricate landscape of FDA and global requirements, ensuring precision in regulatory compliance and quality standards. His extensive experience encompasses cGMP Certification Audits, cGMP Self Inspection Audits, Prior Approval Inspection Readiness Assessments, Supplier Audits, and Due Diligence Assessments.
Luis possesses a distinctive talent and demeanor, enabling him to collaborate effectively with clients, balancing customer processes and products while achieving compliance. He excels at identifying quality and compliance issues to minimize risk for our valued customers. Additionally, Luis has the invaluable qualification of speaking both English and Spanish fluently.
David Ulrich is the Quality Subject Matter Expert (SME) at cGMP Consulting Inc., bringing over 35 years of experience in numerous facets of Quality Assurance. David has strong experience in the standardization and optimization of supply chain quality systems (cGDPs), supply chain temperature management, e-pedigree/track and trace, serialization, and import-export compliance activities.
David has worked directly with the FDA on numerous projects over the years including responding to FDA 483 Inspectional Observations, addressing Warning Letters, Consent Decrees, and more.
David graduated with a Bachelor’s degree in Biology from the University of South Florida and a Bachelor’s of Science in Medical Technology (MT/ASCP) from Governors State University. He pursued a Master’s work in Environmental Engineering at Marquette University and holds a Master’s certificate in Quality Engineering and Regulatory Affair Science from Purdue University.
Sam Piazza is the Chief Strategy Officer at cGMP Consulting Inc., overseeing the demand side of the business with a focus on driving growth and meeting client needs. Sam has been with cGMP Consulting since 2014 and has supervised numerous projects aimed at enhancing security and ensuring data integrity of operational technology systems on plant manufacturing control networks as a Project Manager. Sam has provided validation and project management services for the development, installation, and qualification of automated equipment and software to various pharmaceutical companies in the Chicagoland area. Sam also has extensive experience with automated syringe filling, labeling process lines, and aseptic environmental monitoring.
Sam graduated with a Bachelor of Science in Chemical Engineering from the University of Iowa. Outside the office, Sam enjoys reading, traveling, and spending time with her husband, two boys, and their two dogs.
Kate Aschoff is the Chief Operating Officer at cGMP Consulting Inc., bringing over 7 years of Project Management and Subject Matter Expert (SME) experience within the pharmaceutical industry. Her expertise centers around aseptic fill and finish operations, with a focus on validation projects and operational readiness. Kate excels at balancing clients’ procedural requirements while suggesting improvements for best practices.
Kate’s latest project management scope included procurement, design review, delivery, startup, commissioning, and validation of three new filling lines including vial washers, depyrogenation tunnels, fillers, isolators, cappers, crimp inspection systems, automated loading/unloading systems, and lyophilizers.
In addition, Kate is a subject matter expert in facility design review against FDA regulations, Quality Management System (QMS) development, and consulting on reasonable solutions that balance industry regulations with client needs. She also has experience in radiopharmaceuticals.
As the COO, Kate oversees the supply side of the business, focusing on staff development and ensuring successful project delivery while also strategically building and expanding the team to meet evolving and growing project requirements. Kate thrives on collaborating with potential and existing clients, offering advisory support and solutions to address bottlenecks and enhance project efficiency seamlessly integrating into the client’s processes.
Kate is a proud University of Iowa grad and an Advanced Open Water Scuba diver. She loves traveling to Belize, Cozumel, or anywhere there are fish to see and it’s not cold.
Kevin Nguyen is a Site Manager and Senior Project Engineer at cGMP Consulting Inc., bringing over 6 years of expertise in Commissioning & Qualification (C&Q)/Process Validation for solid dose drugs and combination device assembly/packaging. He leads qualification, validation, risk assessments, and data integrity remediation efforts, collaborating closely with clients on critical projects. Kevin’s team spearheaded the successful implementation and qualification of new packaging processes and facilities.
Kevin graduated with a Bachelor of Science in Chemical Engineering from the University of Iowa. Outside of the office, Kevin enjoys lifting, hiking, camping, reading, and traveling.
Tamara Neumann is an experienced Project Manager of numerous quality system development and gap assessment projects for various industries including dietary supplements, human foods, animal foods, cosmetics, APIs, and pharmaceuticals. She has successfully remediated observations identified through FDA or third-party audits, including addressing Consent Decree, Warning letters, and 483 observations. Tamara also possesses proficiency in dietary supplement label development and remediation efforts. She is skilled in developing foundational quality policies and procedure documents, acceptance specifications, and master manufacturing records across various regulated industries.
Tamara is the Marketing Manager, driving the development and execution of the company’s marketing strategies, managing new service launches, the company website, and social media initiatives. Drawing from over seven years of experience in product development at 3M, she brings a unique perspective from both laboratory and marketing realms of a Fortune 500 company known for innovation.
Tamara graduated with an MBA in Marketing from the University of Minnesota Carlson School of Management and a Bachelor’s degree in Chemical Engineering from the University of North Dakota. Outside of the office, Tamara enjoys family time and staying active with yoga, Pilates, kayaking, boating, traveling, and watching football.
Kevin Linde is an Illinois Professional Engineer with over 27 years of extensive experience in the pharmaceutical industry. He has worked with dozens of clients in the US and done projects in 13 foreign jurisdictions. Kevin has a passion for the industry and can bring creative solutions to meet client needs. With the long and varied industry experience, Kevin has developed an ability to understand and describe client needs. From this understanding cGMP Consulting can develop effective solutions for our clients.
Kevin graduated with a Bachelor of Science in Chemical Engineering from the University of Missouri – Columbia in 1996. He attained his Illinois Professional Engineer license in 2006 and has played a pivotal role in assisting numerous individuals in obtaining their licenses.
Kevin is a proud husband and father to 5 and is a lifelong St. Louis Cardinals fan.
